Tricuspid Regurgitation and Right Ventricular Function in Patients Undergoing Percutaneous Treatment of Mitral Regurgitation

Abstract

Objectives. Patients with severe mitral regurgitation (MR) frequently present with concomitant right ventricular (RV) dysfunction and tricuspid regurgitation (TR). We aimed to investigate the prognostic relevance of RV function, RV dimension, and TR in patients undergoing percutaneous intervention for MR. Methods. Consecutive patients undergoing percutaneous mitral valve intervention were enrolled in the prospective MitraSwiss registry. Tricuspid annular plane systolic excursion (TAPSE), pulmonary artery systolic pressure (PASP), right ventricular pulmonary arterial coupling (RVC, defined as TAPSE/PASP ratio), indexed tricuspid annulus (TA) dimension, and TR severity grade were analyzed at baseline, post procedure, and at 6-month follow-up. The endpoints of all‐cause mortality, hospitalization for heart failure, and the combined endpoint of the 2 were observed during long-term follow-up (up to 4 years). Results. We analyzed 218 patients (mean age, 76 ± 9 years; 36% female). Edge-to-edge mitral valve repair resulted in an increase in TAPSE and RVC ratio and a decrease in indexed TA and PASP, but concomitant TR did not change significantly. In multivariable analysis, RV dysfunction and moderate/severe TR were independently associated with increased all-cause mortality (hazard ratio, 1.61; 95% confidence interval, 1.05-2.46; P=.03 and hazard ratio, 2.10; 95% confidence interval, 1.34-3.29; P<.01, respectively) and moderate/severe TR was further an independent predictor for hospitalization for heart failure and for the combined endpoint. Conclusion. Treatment of MR resulted in favorable changes of RV function and dimension but did not reduce TR in the majority of patients. TR at baseline remained the strongest predictor for outcomes, outperforming parameters of RV function and dimension.

J INVASIVE CARDIOL 2022;34(12):E850-E857. Epub 2022 November 4.

Key words: heart failure, hospitalization for heart failure, mortality, regurgitation, transcatheter mitral valve, tricuspid valve

Tricuspid valve regurgitation (TR) is a frequent finding in patients aged over 70 years, especially in those with mitral valve regurgitation (MR). Indeed, 30%-50% of patients with severe MR also present with concomitant TR.^1,2 Several studies have demonstrated an association between TR severity and survival.^3-9 However, patients with TR frequently present with abnormal right ventricle (RV). A few studies have analyzed the association between RV function, TR, and outcomes, but only with limited assessment of RV function and short follow-up duration.^10-12

Therefore, in the present study, we performed a comprehensive analysis of RV function and dimension including tricuspid annular plane systolic excursion (TAPSE), tricuspid annulus (TA), pulmonary artery systolic pressure (PASP), right ventricular pulmonary arterial coupling (RVC) ratio, and severity of TR in a real-word patient population. We examined these parameters at baseline, studied their course after percutaneous mitral valve repair (PMVR), and further investigated their prognostic impact on clinical long-term outcomes.

Methods

Patient population. Consecutive patients undergoing percutaneous edge-to-edge repair of MR with the MitraClip (Abbott Vascular) or the PASCAL system (Edwards Lifesciences) at the Heart Center Lucerne between November 2009 and December 2021 were analyzed. Five patients were excluded because of mitral valve intervention other than edge-to-edge repair and 11 patients because of concomitant percutaneous tricuspid valve intervention, resulting in a total study population of 218 patients. All patients were enrolled in the prospective MitraSwiss registry. The registry was approved by the regional and national ethics committee and all patients provided written informed consent.

Data collection. Baseline demographic and clinical data were collected. Transthoracic echocardiographic examinations before the intervention (baseline), after the intervention (post procedure) and at the first follow-up visit (6 months post procedure) were assessed. Echocardiographic assessments were performed according to the recent European Association of Cardiovascular Imaging (EACVI) and American Society of Echocardiography (ASE) recommendations.¹³ TR was graded as none, mild, moderate, or severe. For analysis, patients were dichotomized in 2 groups: no/mild TR and moderate/severe TR. PASP was estimated using collapsibility of inferior vena cava (IVC) and TR jet velocity. Pulmonary hypertension (PH) was defined as PASP >40 mm Hg.¹⁴RV systolic dysfunction was defined as TAPSE ≤17 mm.¹³RVC was defined as the TAPSE/PASP ratio. Tricuspid annulus dimension (TA) was measured in RV-focused view at end diastole and indexed for body surface area.¹⁵TA dilation was defined as indexed TA >21 mm/m².¹⁶

Outcome definitions. Echocardiographic parameters characterizing RV function and dimension (TAPSE, indexed TA, PASP, RVC, and TR severity) were assessed at baseline, post procedure, and at 6-month follow-up to examine their course after treatment of left-sided heart disease. During the prospective follow-up period, the endpoints of all-cause mortality, hospitalization for heart failure, and the combined endpoint of all-cause mortality and hospitalization for heart failure were recorded.

Statistical analysis. Normally distributed continuous variables were reported as mean ± standard deviation and non-normally distributed continuous variables were reported as median with inter­quartile range (IQR). For categorical variables, absolute numbers and percentages were calculated. Groups were compared using the t test and the Wilcoxon sign-rank test for continuous variables and the Chi² test for categorial variables. For 2 dependent groups, the paired t test and the McNemar test was performed. Univariate and multivariable Cox regression models were used to assess predictors for the study endpoints. Parameters reaching a P-value <.05 in the univariate model were further subjected to the multivariable model. The Kaplan-Meier method was utilized to develop survival estimates, which were compared with the log-rank test. A P-value <.05 defined statistical significance. Stata, version 16.0 (Stata Corp) was used for the performance of statistical analyses.

Results

Baseline characteristics. A total of 218 patients (mean age, 76 ± 9 years; 36% female) underwent percutaneous edge-to-edge treatment for MR. Concomitant moderate/severe TR at baseline was present in 66/218 patients (31%). These patients were significantly older and suffered from more comorbidities, had a significantly lower left ventricular ejection fraction (LVEF), and presented more often with RV systolic dysfunction, dilated TA, and elevated PASP (Table 1).

Right ventricular parameters. As shown in Figure 1, PMVR led to a significant reduction of mean indexed TA (from 23 ± 3mm/m² at baseline to 21 ± 4 mm/m² post procedure; P<.001) and a slight but significant increase of mean TAPSE (from 18 ± 5 mm to 19 ± 6 mm; P=.01). PASP significantly decreased from 45 ± 14 mm Hg at baseline to 39 ± 11 mm Hg post procedure (P<.001) and 38 ± 11 mm Hg at 6-month follow-up (P=.05). In parallel, there was an immediate and sustained increase of median RVC (TAPSE/PASP) ratio from 0.40 (IQR, 0.28-0.54) at baseline to 0.46 (IQR, 0.33-0.66) post procedure (P<.001) and 0.48 (IQR, 0.35-0.65) at 6-month follow-up (P=.31).

Predictors for mortality. Patients were followed for a median of 793 days (IQR, 330-1503). Ninety-two patients (42%) died and 40 patients (18%) were hospitalized for heart failure during the follow-up period. A univariate Cox regression model identified RV dysfunction (hazard ratio [HR], 1.79; 95% confidence interval [CI], 1.17-2.72; P<.01), PH (HR, 1.68; 95% CI, 1.09-2.61; P=.02), RVC (TAPSE/PASP) ratio >0.4 (HR, 0.59; 95% CI, 0.39-0.90; P=.02), and concomitant moderate/severe TR (HR, 2.40; 95% CI, 1.59-3.63; P<.001) to be significantly associated with mortality. Corresponding Kaplan-Meier estimates are shown in Figure 2. These significant predictors were further subjected to a multivariable analysis, which was calculated in 2 different models. Model 1 included the variables of RV dysfunction (TAPSE ≤17 mm), PH (PASP >40 mm Hg), and moderate/severe TR, whereby RV dysfunction and moderate/severe TR proved to be independent predictors for mortality (HR, 1.61; 95% CI, 1.05-2.46; P=.03 and HR, 2.10; 95% CI, 1.34-3.29; P<.01, respectively). Multivariable model 2 was performed with RVC (TAPSE/PASP) ratio and moderate/severe TR and only TR was independently predictive for increased mortality (Table 2).

Predictors for hospitalization for heart failure. During the follow-up period, 40 patients (18%) were hospitalized for heart failure. Univariate Cox regression model revealed lower LVEF, higher LVEDV as well as the presence of functional MR, RV dysfunction, and concomitant moderate/severe TR as significant risk factors for hospitalization after mitral valve intervention (Table 3). In multivariable analysis, only moderate/severe TR (HR, 2.37; 95% CI, 1.14-4.91; P=.02) remained an independent predictor for hospitalization due to heart failure.

Predictors for the combined endpoint. The combined endpoint of mortality and hospitalization for heart failure was observed in 106/218 patients (49%). It occurred significantly more often among patients with lower LVEF, RV dysfunction, PH, and concomitant moderate/severe TR. In multivariable analysis, only moderate/severe TR (HR, 1.83; 95% CI, 1.18-2.84; P<.01) proved to be independently associated with the combined endpoint (Table 4).

Discussion

The aim of the present study was to comprehensively investigate the interaction and evolution of RV function and dimension, pulmonary pressure, and grade of concomitant TR in patients undergoing percutaneous treatment for MR. In addition, we analyzed the impact of these parameter on the risk of admission for heart failure and survival during a prolonged follow-up period of up to 4 years. To the best of our knowledge, this is the first study to analyze all of these parameters in a prospective, real-world patient population. We found that successful treatment of relevant MR led to an immediate and sustained reduction in RV size and systolic pressure as well as an improvement in RV systolic function (Figure 2). Despite successful reduction of MR resulting in improved RV parameters, severity of concomitant TR did not change in most patients (Figure 1). Moreover, we found moderate/severe TR at baseline to be an independent predictor for increased all-cause mortality (HR, 2.17), hospitalization for heart failure (HR, 2.37), and the combined endpoint of the 2 (HR, 1.83). Additionally, RV systolic dysfunction was associated with increased mortality (HR, 1.61).

Right ventricular size and function. RV systolic dysfunction at baseline was found in about half of the patients (53%). There was an immediate and sustained increase in mean TAPSE after treatment of MR, which has been previously reported.^17,18 The presence of RV dysfunction at baseline was independently predictive for long-term mortality (HR, 1.61; 95% CI, 1.05-2.46; P=.03). This finding corresponds with a recent systematic review and meta-analysis by Meijerink et al,¹⁹ wherein RV dysfunction was associated with all-cause mortality (HR, 1.86; 95% CI, 1.45-2.38). Dilation of the TA was present in 62%, especially among patients with moderate/severe TR (80%). Interestingly, there was an immediate significant decrease of the TA diameter by 2 mm after PMVR, which sustained through 6 months of follow-up. However, TA diameter did not predict outcomes. In a recent study, Dietz et al²⁰ analyzed a total of 1292 patients with moderate/severe TR and reported RV dysfunction but not TA dilation as a significant predictor of 5-year mortality.

Pulmonary hypertension. In our study, PASP at baseline was 45 ± 14 mm Hg, which was significantly reduced after PMVR to 39 ± 11 mm Hg and slightly further reduced at 6-month follow-up. This finding is in line with previous studies describing a significant reduction in PASP after PMVR.^4,21-23 In univariate analysis, PASP was associated with increased mortality (HR, 1.68; 95% CI, 1.09-2.61; P=.02). This result is consistent with a recent systematic review and meta-analysis reporting an association between PH and mortality (HR, 1.70).¹⁹

Right ventricular pulmonary arterial coupling. RVC, the calculated TAPSE/PASP ratio, has recently been established as a prognostic parameter for patients with heart failure.^24,25 This novel index is coupling contractility of RV (TAPSE) and generated force (PASP) and therefore describes the efficiency of RV in transferring stroke work to the pulmonary vasculature. In a physiological state, RV contractility rises proportionally to an increase in afterload maintaining a stable RVC ratio. A decreased RVC ratio results from an inadequate contractility of the RV in relation to the afterload, indicating a decompensated state.²⁶ A recent study analyzed 444 patients with relevant TR from the TriValve registry. It described a median RVC ratio of 0.406 mm/mm Hg (IQR, 0.308-0.567) and further reported a RVC ratio >0.406 as an independent predictor for a decreased risk of mortality (HR, 0.57; 95% CI, 0.35-0.93).²⁶ In accordance with these findings, we calculated a median RVC of 0.40 mm/mm Hg (IQR, 0.28-0.54) in our study. In univariate analysis, we similarly found RVC >0.406 to be significantly associated with lower mortality rates, with a similar HR of 0.59 (95% CI, 0.39-0.90). However, RVC did not remain statistically significant in multivariable analysis, indicating that the presence of RV dysfunction and moderate/severe TR seem to be more powerful predictors of outcome in patients undergoing PMVR.

Tricuspid regurgitation. Concomitant TR of grade moderate or severe was frequently present (in 31% of patients). Although percutaneous treatment of relevant MR led to an improvement of RV function and a reduction of RV size and PASP, the proportion of patients with moderate/severe TR did not significantly decrease (Figure 2). The proportion of patients with severe TR was reduced at 6-month follow-up due to a high mortality rate among this subgroup (27% of patients with baseline severe TR had died at 6-month follow-up). Several studies have previously described an association between concomitant TR and decreased 1-year survival in patients undergoing PMVR.^5-9 In our study, we found the presence of moderate/severe TR as a strong and independent predictor for long-term survival (up to 4 years; HR, 2.10) and furthermore for rate of rehospitalization due to heart failure (HR, 2.37) and the combined endpoint of both (HR, 1.83). This finding emphasizes the importance of relevant TR at baseline for clinical long-term outcome of patients undergoing PMVR. The presence of TR emerges as a major prognostic factor, independent of RV size, level of PASP, or RVC ratio.

Clinical implications. We analyzed a real-world patient population with relevant MR and found a substantial number of patients (31%) presenting with moderate or severe TR. The evidence that patients with TR have worse prognosis is growing stepwise, but as medical treatment and surgical intervention both have only poor outcomes, these patients are mainly left untreated.^27-29 With regard to the increasing incidence of valvular heart disease with age and the progressive aging of the population, this patient group with potential need for treatment will further growth. Therefore, transcatheter tricuspid valve interventions emerge as a new possibility to effectively modify the course of TR and to improve clinical outcome and prognosis of patients suffering from relevant TR.^30-32 Certainly, more research is needed to evaluate optimal therapeutical management of this vulnerable and often seriously ill patient population.

Study limitations. Several limitations apply to this study. It is a single-center study and therefore, a limited generalizability must be considered. Furthermore, the sample size was relatively small, and there was no echocardiographic core lab, so interobserver variability must be taken into consideration.

Conclusion

Treatment of left-sided heart disease led to an improvement in RV function, downsizing of TA, and reduction of pulmonary pressure. However, severity of TR did not significantly improve in the majority of patients. Moderate/severe TR and RV dysfunction were predictive for impaired long-term survival. Moderate/severe TR was further a predictor for higher risk of hospitalization for heart failure.

Affiliations and Disclosures

From the Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Wolfrum serves a proctor for Biosensors. Dr Stämpfli reports consulting and speaker fees from Alnylam, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Pfizer, and Takeda. Dr Kobza reports institutional grants from Abbott, Biosense-Webster, Biotronik, Boston Scientific, Medtronic, and SIS Medical. Dr Toggweiler serves as a proctor and consultant for Abbott, Biosensors, Boston Scientific, Edwards Lifesciences, and Medtronic;  consultant for Shockwave, Teleflex, Medira, atHeart Medical, Polares Medical, and Veosource; institutional research grants from Boston Scientific, Biosensors, and Fumedica AG; and holds equity in Hi-D Imaging. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript accepted July 8, 2022.

Address for correspondence: Prof Dr Stefan Toggweiler, Heart Center Lucerne, Spitalstrasse, 6000 Luzern, Switzerland. Email: stefan.toggweiler@luks.ch

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